FDA.reportPublic FDA data

Allopurinol

Product NDC
50090-5168
11-digit product format
500905168
Labeler code
50090
Product ID
50090-5168_3657d93a-6a51-4e9f-ac52-4eeeead96344
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA203154
Marketing category
ANDA
Marketing start
2015-04-29
Substance
ALLOPURINOL
Active strength
100 mg/1
Pharmacologic classes
Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Allopurinol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALLOPURINOL100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii63CZ7GJN5I
Rxcui197319

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ee55bab-4ea8-ac26-c688-380cfbcd5c03Product name720260127
de89a493-168f-43fa-9852-1f15e00dbb17Product name120221110
4a2a34d6-1853-423b-9e0c-360370b95802Product name120171006

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5168-3Allopurinol30 in 1 BOTTLETABLET309
50090-5168-4Allopurinol90 in 1 BOTTLETABLET909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5168-3EA - Each50090-516857b86f11-c5c9-4375-86c9-ddfd511a81f812022-12-07
50090-5168-4EA - Each50090-5168b200005c-4eb2-4646-8b2a-853666c4be1512022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5168ALLOPURINOL TABLET [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 2 package rows20240417_71accbc4-8bd7-4d22-ae53-c7b044a15ffa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197319allopurinol 100 MG Oral TabletPSN71accbc4-8bd7-4d22-ae53-c7b044a15ffa9
197319allopurinol 100 MG Oral TabletSCD71accbc4-8bd7-4d22-ae53-c7b044a15ffa9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5168-35009051680330 TABLET in 1 BOTTLE (50090-5168-3) 30 tablet2020-09-240000-00-00NoNoCurrent
50090-5168-45009051680490 TABLET in 1 BOTTLE (50090-5168-4) 90 tablet2020-09-240000-00-00NoNoCurrent